US20160287370A1 - Bioresorbable, endoscopic dcr stent - Google Patents
Bioresorbable, endoscopic dcr stent Download PDFInfo
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- US20160287370A1 US20160287370A1 US15/085,308 US201615085308A US2016287370A1 US 20160287370 A1 US20160287370 A1 US 20160287370A1 US 201615085308 A US201615085308 A US 201615085308A US 2016287370 A1 US2016287370 A1 US 2016287370A1
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract
A stent and associated method maintains a lacrimal duct in an open, unobstructed state following DCR. The self-expanding, bioresorbable tubular structure has a diameter in the range of 5-8 mm and a length in the range of 4-8 mm following self-expansion. A mesh structure includes struts interconnected through shape-memory hinge regions that open to facilitate expansion. The structure may assume an hour-glass form having a necked-down waist region and flared opposing end regions following expansion to assist in maintaining the stent in position. The stent is compressed to a diameter in the range of 1-3 mm, loaded into an inserter tool, and positioned into a lacrimal duct having an inner wall. The stent is inserted into the lacrimal duct, whereby the stent self-expands into a structure that conformally applies outward pressure to the inner wall of the lacrimal duct to hold open the duct, and the inserter tool is removed.
Description
- This application claims priority to U.S. Provisional Patent Application Ser. No. 62/140,170, filed Mar. 30, 2015, the entire content of which is incorporated herein by reference.
- This invention relates generally to dacryocystorhinostomy, or DCR, and, more particularly, to a bioresorbable stent to keep the neo-ostium open, and decrease granulation and scarring after the surgery.
- Epiphora, or excessive tearing, can result from several different etiologies but blocked lacrimal ducts is one of the most common reasons. This blockage is frequently fixed with a surgical procedure called dacryocystorhinostomy, or DCR, which opens the lacrimal system into the nose. At the end of the procedure, tubes are commonly placed through the puntae of the eye, passed into the nose, and tied internally into the nose.
- Currently there is debate as to whether the tubes benefit the procedure, or worsen the results by causing granulation tissue and subsequent scarring. The currently used Crawford tubes are kept in place for months before removal. They are uncomfortable to patients, as they completely plug the outflow of the tears causing epiphora (the reason the procedure was performed in the first place), since no flow is allow through the system while the tubes are in place. Those of skill in this art will appreciate that alternative devices and methods would improve the post-op DCR procedures.
- This invention improves upon DCR procedures post-op by providing a bioresorbable stent to keep the neo-ostium open while decreasing granulation and scarring after the surgery. As no tubes or other structures would be left in the punctae, post-operative epiphora should also be greatly reduced.
- A stent according to the invention for maintaining a lacrimal duct in an open, unobstructed condition following a dacryocystorhinostomy (DCR) procedure comprises a self-expanding, bioresorbable tubular structure having a diameter in the range of 5-8 mm and a length in the range of 4-8 mm following self-expansion. In the preferred embodiment, structure is a mesh comprising struts interconnected through shape-memory hinge regions that open to facilitate expansion. To achieve bioresorbability, the stent is preferably composed of a mixture of poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) or poly glycolic acid (PGA) and PGLA. The structure may include a steroid and/or Mitomycin-C.
- In a preferred embodiment, the structure assumes an hour-glass form having a necked-down waist region and flared opposing end regions following expansion to assist in maintaining the stent in position. The structure may have a diameter in the range of 1-3 mm when compressed for insertion.
- A method of maintaining a lacrimal duct in an open, unobstructed condition following a dacryocystorhinostomy (DCR) procedure, comprises the step providing a self-expanding, bioresorbable stent having a diameter in the range of 5-8 mm and a length in the range of 4-8mm following self-expansion. The stent is compressed, loaded into an inserter tool, and the tool is positioned into a lacrimal duct having an inner wall. The stent is inserted into the lacrimal duct, whereby the stent self-expands into a structure that conformally applies outward pressure to the inner wall of the lacrimal duct to hold open the duct; and the inserter tool is removed from the operative site.
-
FIG. 1 is a drawing that illustrates a self-expanding, bioresorbable stent according to the invention; -
FIG. 2 shows the stent of claim 1 compressed and loaded into an inserter instrument; and -
FIG. 3 is a simplified illustration that shows a deployed stent assuming an hour-glass profile. - In broad and general terms, this invention resides in a self-expanding, bioresorbable stent used to hold open the lacrimal duct opening after dacryocystorhinostomy (DCR). As such, as shown in
FIG. 1 , the stent would be in the form of a self-expanding tube-like structure 100 measuring 5-8 mm in diameter (d) and 4-8 mm in length (l) following self-expansion. - To achieve bioresorbability, the stent is composed of a mixture of poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) or poly glycolic acid (PGA) and PGLA, with structural integrity lasting a variable length of time depending on the exact utility required. Typically this would be in the range of 3-6 weeks. While the structure may be solid, in the preferred embodiments the structure is a
mesh comprising struts 102 interconnected throughhinge regions 104. The hinges connecting each strut provide the spring action operative to expand the stent following placement. - The structure of the stent enables the device to conform to the shape of the opening created in the lacrimal system by the surgeon. When fully expanded, the stent would hold the shape of a circular ring in cross section, but due to the malleable nature of the materials it could hold the shape as an oval, ellipse, circle or irregular shape depending upon the anatomy of the lacrimal duct.
- In terms of the operative procedure, the stent is compressed and loaded into an introducer apparatus to then be placed into the neo-ostium. When compressed, the diameter of the device is roughly 2 mm, while the length may increase by several millimeters.
FIG. 2 shows the stent of claim 1 compressed and loaded into aninserter instrument 202.FIG. 3 is a simplified illustration that shows a deployed stent inserted into the neo-ostium of thelacrimal duct 300. As shown, the preferred embodiment the structure includes awaist region 302 in the middle of the device, with theends Small prongs 310, protruding from the intra-luminal portion of the device, may be provided to assist in holding the stent in position. - DCR surgery is limited by granulation and scarring. Studies range from 2.6% to 20.7% as to the incidence of granulation after the procedure, leading to scarring and revision surgery. Thus, while one important function of the stent is to physically hold the surgically created ostium open following the procedure, in the preferred embodiment the device is steroid-coated to apply a high steroid dose directly to the site of surgical trauma while avoiding the deleterious effects of systemic steroids. A highly hydrophobic steroid would reduce the systemic absorbtion as well as reduce the absorbtion across the tissues into the orbit and globe. Analagous stents in other parts of the nose have shown the ability to reduce scarring by up to 70%. Alternatively, other compounds could be used to coat the stent, such as Mitomycin-C.
Claims (14)
1. A stent for maintaining a lacrimal duct in an open, unobstructed condition following a dacryocystorhinostomy (DCR) procedure, comprising:
a self-expanding, tubular structure composed of a bioresorbable material; and
wherein the structure measures 5-8 mm in diameter and 4-8 mm in length following self-expansion.
2. The stent of claim 1 , wherein the structure is a mesh comprising struts interconnected through hinge regions.
3. The stent of claim 1 , wherein the stent is composed of a mixture of poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) or poly glycolic acid (PGA) and PGLA.
4. The stent of claim 1 , wherein the structure includes a highly hydrophobic steroid.
5. The stent of claim 1 , wherein the structure is coated with Mitomycin-C.
6. The stent of claim 1 wherein, following self-expansion, the structure assumes an hour-glass form having a necked-down waist region and flared opposing end regions.
7. The stent of claim 1 , wherein the structure has a diameter in the range of 1-3 mm when compressed for insertion.
8. A method of maintaining a lacrimal duct in an open, unobstructed condition following a dacryocystorhinostomy (DCR) procedure, comprising the steps of:
providing the stent of claim 1 ;
compressing the stent, and loading the stent into an inserter tool;
positioning the inserter tool into a lacrimal duct having an inner wall;
inserting the stent into the lacrimal duct, whereby the stent self-expands into a structure that conformally applies outward pressure to the inner wall of the lacrimal duct to hold open the duct; and
removing the inserter tool.
9. The method of claim 8 , wherein the stent has a diameter in the range of 1-3 mm when compressed for insertion.
10. The method of claim 8 , wherein the stent expands into a structure measuring 5-8 mm in diameter and 4-8 mm in length.
11. The method of claim 8 , wherein the stent expands into a structure having an hour-glass form with a necked-down waist region and flared opposing end regions.
12. The method of claim 8 , wherein the stent is composed of a mixture of poly lactic acid (PLA) and poly lactic-co-glycolic acid (PLGA) or poly glycolic acid (PGA) and PGLA.
13. The method of claim 1 , wherein the stent delivers a highly hydrophobic steroid.
14. The method of claim 1 , including a coating of Mitomycin-C.
Priority Applications (1)
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US15/085,308 US20160287370A1 (en) | 2015-03-30 | 2016-03-30 | Bioresorbable, endoscopic dcr stent |
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US201562140170P | 2015-03-30 | 2015-03-30 | |
US15/085,308 US20160287370A1 (en) | 2015-03-30 | 2016-03-30 | Bioresorbable, endoscopic dcr stent |
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US15/085,308 Abandoned US20160287370A1 (en) | 2015-03-30 | 2016-03-30 | Bioresorbable, endoscopic dcr stent |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107137789A (en) * | 2017-06-02 | 2017-09-08 | 天津工业大学 | A kind of preparation method and applications of the ureter rack tube with SME |
CN107811629A (en) * | 2017-09-30 | 2018-03-20 | 温州医科大学附属眼视光医院 | A kind of lacrimal passage pressure detecting instrument of the pressure acquisition signal based on CS1237 chips, piezoresistance sensor and single-chip microcomputer |
CN115737229A (en) * | 2022-10-26 | 2023-03-07 | 江苏省人民医院(南京医科大学第一附属医院) | Lacrimal sac nasal cavity introducer and drainage bracket |
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US20080234309A1 (en) * | 2006-09-13 | 2008-09-25 | Elixir Medical Corporation | Macrocyclic lactone compounds and methods for their use |
US8142422B2 (en) * | 2004-04-21 | 2012-03-27 | Acclarent, Inc. | Devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat |
US9039657B2 (en) * | 2004-08-04 | 2015-05-26 | Acclarent, Inc. | Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders |
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2016
- 2016-03-30 US US15/085,308 patent/US20160287370A1/en not_active Abandoned
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US8142422B2 (en) * | 2004-04-21 | 2012-03-27 | Acclarent, Inc. | Devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat |
US9039657B2 (en) * | 2004-08-04 | 2015-05-26 | Acclarent, Inc. | Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders |
US20060276738A1 (en) * | 2005-06-06 | 2006-12-07 | Becker Bruce B | Lacrimal drainage bypass device and method |
US20080234309A1 (en) * | 2006-09-13 | 2008-09-25 | Elixir Medical Corporation | Macrocyclic lactone compounds and methods for their use |
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CN107137789A (en) * | 2017-06-02 | 2017-09-08 | 天津工业大学 | A kind of preparation method and applications of the ureter rack tube with SME |
CN107811629A (en) * | 2017-09-30 | 2018-03-20 | 温州医科大学附属眼视光医院 | A kind of lacrimal passage pressure detecting instrument of the pressure acquisition signal based on CS1237 chips, piezoresistance sensor and single-chip microcomputer |
CN115737229A (en) * | 2022-10-26 | 2023-03-07 | 江苏省人民医院(南京医科大学第一附属医院) | Lacrimal sac nasal cavity introducer and drainage bracket |
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